Clinical trial · Interventional
CARINAE for Stress Relief in Perioperative Care
CARINAE: A Digital Health Intervention for Stress Relief in Perioperative Care: Clinical Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Preventing pre-surgical stress can help patients achieve positive outcomes on health and well-being. However, very few patients receive adequate stress relief support prior to a surgical procedure. Provision of education and information about the surgery can be a crucial component of the preoperative experience and is inversely related to levels of preoperative anxiety. However, resource constraints make face-to-face education sessions untenable, given cost considerations and time investment by trained health personnel. Interventions based on mobile health (mHealth) technologies, geared towards increasing familiarity with surgical procedures and hospital environments have been shown to help patients feel informed about possible benefits and risks of available treatment options. mHealth apps and Virtual Reality (VR) can offer patients experience in the perioperative environment that can be helpful in empowering patients and enhancing a more positive experience, while reducing stress. However, available applications focus only on providing informative content, neglecting the importance of patient empowerment with a more robust educational curriculum. According to this, the Software as a Medical Device (SaMD) CARINAE, aims to support patients and caregivers during the whole perioperative process. SaMD CARINAE consists of an mHealth mobile application for patients and caregivers, a Virtual Reality headset for patients, and a web application for healthcare professionals.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Cardiac Valve Replacement | — | UNRESOLVED | — |
| Cardiopulmonary Bypass Surgery | — | UNRESOLVED | — |
| Coronary Artery Bypass Surgery | — | UNRESOLVED | — |
| Hip Replacement | — | UNRESOLVED | — |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Knee Replacement | — | UNRESOLVED | — |
| Orthognathic Surgery | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SaMD CARINAE | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control Group
- description
- Patients will follow the usual care procedures and after each procedure they answer questionnaires related to pain and stress levels (VAS), Anxiety and depression levels (HADS), health-related quality of life (HRQoL), mental wellbeing (SWEMWBS), self-efficacy (GSE) and Patient Activation status (PAM-13).
- type
- EXPERIMENTAL
- label
- SaMD CARINAE
- description
- Intervention group will be exposed to the use of SaMD CARINAE for 2 months approximately, a patientcentred digital health support program. The intervention trial will include a total of 4 visits: 1. Baseline (2-4 weeks before surgery); 2. Hospital admission (1-3 days before surgery); 3. Hospital discharge (1 week after the surgery approx.); 4. Post-operative day 14 (2 weeks after the surgery approx). After each visit and intervention trial with SaMD CARINAE the experimental group answer the same questionnaires of the control group, above mentioned Participants allocated to the intervention group will also be asked to complete questionnaires about usability, satisfaction and subjective experience.
- interventionNames
- Device: SaMD CARINAE
Primary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
Show eligibility criteria text
Inclusion Criteria: * Patients planned for one of the selected surgery types: * Cardiopulmonary bypass (CPB) surgery (Maastricht UMC+) * Coronary artery bypass surgery (Maastricht UMC+) * Cardiac valve replacement (SAS, Maastricht UMC+) * Prostate, kidney, and bladder cancer surgery (INRCA) * Hip and knee replacement (HSJD; Parc Tauli) * Maxillofacial surgery (HSJD) * Orthognathic surgery (HSJD) * Scoliosis (HSJD) * Signed informed consent (by patient or legal guardian in paediatric cases). * Patients ≥ 18 years old, except for paediatric Hospital San Joan de Deu (HSJD) ≥ 8 years old. * Patient owns a smartphone with Android version 4.4 or above. * Patient (or legal guardian/caregiver in paediatric cases) is able to demonstrate basic digital literacy (e.g. knows how to communicate through instant messaging apps or similar). Exclusion Criteria: * Dementia. * Pregnant women. * Inability to understand the local language. * Allergic to dedicated wearable material (stainless steel and silicone). * Currently enrolled in a different clinical trial.
References
Publications (10)
- BACKGROUNDCrichton, N. Visual analogue scale (VAS). J Clin Nurs. 2001; 10(5): 706-6.
- BACKGROUNDZigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x. PMID 6880820
- BACKGROUNDWatson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063. PMID 3397865
- BACKGROUNDStewart-Brown S, Tennant A, Tennant R, Platt S, Parkinson J, Weich S. Internal construct validity of the Warwick-Edinburgh Mental Well-being Scale (WEMWBS): a Rasch analysis using data from the Scottish Health Education Population Survey. Health Qual Life Outcomes. 2009 Feb 19;7:15. doi: 10.1186/1477-7525-7-15. PMID 19228398
- BACKGROUNDSchwarzer, R., & Jerusalem, M. Generalized Self-Efficacy scale. In J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user's portfolio. Causal and control beliefs. Windsor, UK: NFER-NELSON. 1995; 35-37.
- BACKGROUNDHibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x. PMID 15230939
- BACKGROUNDBrooke, J. SUS-A quick and dirty usability scale. Usability evaluation in industry. 1996; 189(194): 4-7.
- BACKGROUNDReichheld FF. The one number you need to grow. Harv Bus Rev. 2003 Dec;81(12):46-54, 124. PMID 14712543
- DERIVEDKondylakis H, Giglioli IAC, Katehakis D, Aldemir H, Zikas P, Papagiannakis G, Hors-Fraile S, Gonzalez-Sanz PL, Apostolakis K, Stephanidis C, Nunez-Benjumea FJ, Banos-Rivera RM, Fernandez-Luque L, Kouroubali A. Stress Reduction in Perioperative Care: Feasibility Randomized Controlled Trial. J Med Internet Res. 2025 Jan 7;27:e54049. doi: 10.2196/54049.